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CO-CODAMOL is a brand name for Codeine. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Codeine is indicated in patients older than 12 years of age for the treatment of acute moderate pain which is not considered to be relieved by other analgesics such as paracetamol or ibuprofen (alone).
Verbatim from this product's MHRA label. Tap a section to expand.
4). Posology Adults One to two tablets every four to six hours when necessary to a maximum of eight tablets per 24 hours. Elderly The dosage should be reduced. Hepatic impairment The dosage should be reduced.
Paediatric population:
Children aged 16 to 18 years: One to two tablets every six hours when necessary to a maximum of eight tablets per 24 hours.
Children aged 12 to 15 years:
One tablet every six hours when necessary to a maximum of four tablets per 24 hours. 4). The duration of treatment should be limited to 3 days and if no effective pain relief is achieved the patients/carers should be advised to seek the views of a physician.
Dosage should be adjusted accordingly to the severity of the pain and the response of the patient. However, it should be kept in mind that tolerance to codeine can develop with continued use and that the incidence of untoward effects is dose related.
Doses of codeine higher than 60 mg fail to give commensurate relief of pain but merely prolong analgesia and are associated with an appreciable increased incidence of undesirable side effects. Method of administration For oral use.
4) Gastrointestinal disorders Not Known: Chronic hepatic necrosis, liver damage, Acute pancreatitis, active hepatitis, constipation, GI irritation, biliary spasm, nausea, vomiting, loss of appetite, dry mouth, paralytic ileius or toxic megacolon.
Vascular disorders Not Known:
Toxic myocarditis, bradycardia, palpitations, hypotension.
Metabolism and nutrition disorders Not Known:
High anion gap metabolic acidosis Blood and lymphatic system disorders Not Known: blood dyscrasias including methaemoglobinaemia, neutropenia, pancytopenia, leukopenia, thrombocytopenic purpura, haemolytic anaemia and agranulocytosis.
Immune system disorders Hypersensitivity including skin rash may occur.
Not known: anaphylactic shock, angioedema Renal and urinary disorders Uncommon:
Nephrotoxicity, papillary necrosis Not Known: Ureteral spasm, antidiuretic effect.
Skin and subcutaneous tissue disorders Rare:
Skin rash, drug fever, mucosal lesions.
Not Known:
Urticaria, difficulty breathing, increased sweating, redness or flushed face. Eye disorders Not Known: blurred or double vision.
General disorders and administration site conditions Uncommon:
Drug withdrawal syndrome Other Trembling, unusual tiredness or weakness, malaise, miosis, hypothermia. Effects of withdrawal -abrupt withdrawal precipitates a withdrawal syndrome. Symptoms may include tremor, insomnia, nausea, vomiting, sweating and increase in heart rate, respiratory rate and blood pressure.
i. Paracetamol: • Hypersensitivity to paracetamol or any of the excipients. ii. Codeine: • Acute respiratory depression • Hypersensitivity to codeine or other opioid analgesics, or to any of the excipients. • Liver disease. • Acute alcoholism.
• Use should be avoided in patients with raised intracranial pressure or head injury (in addition to the risk of respiratory depression and increased intracranial pressure, may affect pupillary and other responses vital for neurological assessment).
6) • In patients for whom it is known they are CYP2D6 ultra-rapid metabolisers • Concomitant use of monoamine oxidase inhibitors (MAOIs) or within two weeks of MAOI discontinuation as severe CNS excitation or depression (including hypertension or hypotension) may occur.
g. pseudomembranous colitis) Not to be used in children of 12 years and under. 4 Special warnings and precautions for use Co-codamol 30mg/500mg Tablets may cause drowsiness. Co-codamol 30mg/500mg Tablets should be given in reduced doses or with caution to elderly patients or debilitated patients or patients with hypothyroidism, asthma, decreased respiratory reserve, adrenocortical insufficiency, prostatic hypertrophy, hypotension, shock, inflammatory or obstructive bowel disorders, urethral stricture, convulsive disorders, myasthenia gravis.
It should be avoided or the dose reduced in patients with hepatic or renal impairment. Avoid use during an acute asthma attack. Risks from concomitant use of opioids and benzodiazepines Concomitant use of opioids, including codeine, with benzodiazepines may result in sedation, respiratory depression, coma and death.
Because of these risks, reserve concomitant prescribing of opioids and benzodiazepines for use in patients for whom alternative treatment options are inadequate. 5). Risks from concomitant use of opioids and alcohol Concomitant use of opioids, including codeine, with alcohol may result in sedation, respiratory depression, coma and death.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Codeine in United Kingdom.
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Brand names are compiled from public regulatory records for active-ingredient mapping only. Drugvu is not affiliated with any manufacturer. This is not medical advice.
NOTE tolerance diminishes rapidly after withdrawal so a previously tolerated dose may prove fatal. Other effects -Most reports of adverse reactions to paracetamol relate to overdosage with the drug. Regular prolonged use of codeine is known to lead to addiction and tolerance.
Symptoms of restlessness and irritability may result when treatment is then stopped. Prolonged use of a painkiller for headaches can make them worse. 4). Pyroglutamic acidosis may occur as a consequence of low glutathione levels in these patients Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important.
It allows continued monitoring of the benefit/risk balance of the medicinal product. uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
5) CYP2D6 metabolism Codeine is metabolised by the liver enzyme CYP2D6 into morphine, its active metabolite. If a patient has a deficiency or is completely lacking this enzyme an adequate analgesic effect will not be obtained. Estimates indicate that up to 7% of the Caucasian population may have this deficiency.
However, if the patient is an extensive or ultra-rapid metaboliser there is an increased risk of developing side effects of opioid toxicity even at commonly prescribed doses. These patients convert codeine into morphine rapidly resulting in higher than expected serum morphine levels.
General symptoms of opioid toxicity include confusion, somnolence, shallow breathing, small pupils, nausea, vomiting, constipation and lack of appetite. In severe cases this may include symptoms of circulatory and respiratory depression, which may be life-threatening and very rarely fatal.
3). All children received doses of codeine that were within the appropriate dose range; however there was evidence that these children were either ultra-rapid or extensive metabolisers in their ability to metabolise codeine to morphine.
Children with compromised respiratory function Codeine is not recommended for use in children in whom respiratory function might be compromised including neuromuscular disorders, severe cardiac or respiratory conditions, upper respiratory or lung infections, multiple trauma or extensive surgical procedures.
These factors may worsen symptoms of morphine toxicity. Opioid analgesics should be avoided in patients with biliary tract disorders or used in conjunction with an antispasmodic. Administration of pethidine and possibly other opioid analgesics to patients taking a monoamine oxidase inhibitor (MAOI) has been associated with very severe and sometimes fatal reactions.
5). Caution should be exercised when using paracetamol prior to (less than 72 hours) or concurrently with intravenous busulfan (see section